Kornimate/medical-research-clean huggingface dataset:
clinical utility study for myprostatescore+

Conditions: Prostate Cancer

Summary: this is a national-level research study of urologists. the purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

the results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. the data from this study will be submitted to a national journal for publication. the study plans to enroll up to 250 physicians. upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as clinical performance and value vignettes (cpv®). cpvs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. in each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of cpv administration to be approximately 45 - 60 minutes. all responses to the cases will be completed online and will be kept confidential. over 2 cpv administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours. if physicians are randomized to an intervention group in this study, they will receive education materials on a novel diagnostic test after the first round of cpv administration. they are asked to review these materials before moving to the next cpv administration round. time to review education materials is estimated to be approximately 15 minutes. depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. if they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility criteria:
inclusion criteria: * board-certified urologists for at least two years * averaging at least 20 hours per week of clinical and patient care duties over the last six months * routinely evaluate patients at risk for prostate cancer in their practice * practicing in the u.s. * english speaking * access to the internet * informed, signed and voluntarily consented to be in the study exclusion criteria: * non-english speaking * unable to access the internet * not practicing in the u.s. * not averaging at least 20 hours per week of clinical or patient care duties over the last six months * previous exposure to the myprostatescore test * do not voluntarily consent to be in the study
randomized clinical trial of adipose-derived stem cells in the treatment of pts with st-elevation myocardial infarction

Conditions: Myocardial Infarction; Coronary Arteriosclerosis; Cardiovascular Disease; Coronary Disease

Summary: the purpose of this study is to establish safety and feasibility of utilizing adipose-derived stem and regenerative cells (adrc's) in patients who have suffered a st-elevation acute myocardial infarction.

subjects who have coronary artery disease and have suffered a st-elevation acute myocardial infarction will be evaluated for eligibility in this study. eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which adrc's will be isolated from the lipoaspirate. according to randomization subjects will receive either adrc's or placebo.

Eligibility criteria:
key inclusion criteria: * acute myocardial infarction (ami) * clinical symptoms consistent with ami for a minimum of 2 and a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (pci), and unresponsive to nitroglycerin * successful revascularization of the culprit lesion in the major epicardial vessel * area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary pci * left ventricular ejection fraction (lvef) ≥30% and ≤50% by left ventricular angiography at the time of successful revascularization. * ability to undergo liposuction key exclusion criteria: * prior mi, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (chf) * more than 24 hours after acute pci * significant valvular disease * more than twelve hours between the onset of first symptoms of ami and revascularization * hemodynamic instability within 24 hours prior to randomization * neoplasia * acute or chronic bacterial or viral infectious disease * pacemaker, icd or any other contra-indication for mri * lvef \ 50% by left ventricular angiography * moderate or severe copd

Keywords: adrc stem cells myocardial infarction stemi heart disease coronary artery disease coronary disease st-elevation ami interventional cardiology heart attack
interventional treatment of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: the study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.

the best strategy of treatment patients with chronic thromboembolic pulmonary hypertension is pulmonary thromboendarterectomy. in 5-30% of cases after pulmonary thromboendarterectomy residual pulmonary hypertension is persisted. the technique of radiofrequency pulmonary artery denervation in patients with idiopathic pulmonary arterial hypertension (type i) is known and was assessed during clinical investigation. in this study radiofrequency pulmonary artery denervation technique may be applied in patients with residual pulmonary hypertension after pulmonary thromboendarterectomy (type iv)

Eligibility criteria:
inclusion criteria: * presence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy according to right heart catheterization: mean pulmonary artery pressure \> 25 mm hg or pulmonary vascular resistance \> 400 dyn x sec x cm-5 exclusion criteria: * no evidence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy (mean pulmonary artery pressure \<25 m hg). * refusal of a patient to participate in the study. * the presence of severe concomitant diseases of the cardiovascular system and lungs, leading to pulmonary hypertension * the presence of other severe comorbidities that may result in death within a year.

Keywords: chronic thromboembolic pulmonary hypertension, navigation system, ablation
gentamicin versus clindamycin versus normal saline lavage in axilla

Conditions: Breast Cancer

Summary: the patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing lavages with normal saline (group 1), patients undergoing lavage gentamicin solution (group 2) and patients undergoing lavage with a clindamycin solution (group 3). drainage volume discharge is investigated

the patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing 2 lavages with 500 ml normal saline (group 1), patients first undergoing lavage with 500 ml normal saline followed by a second lavage with a 500 ml of a gentamicin (240 mg) solution (group 2) and patients first undergoing lavage with 500 ml normal saline followed by a second lavage with 500ml of a clindamycin (600mg) solution (group 3). drainage volume discharge is investigated

Eligibility criteria:
inclusion criteria: * diagnosis of breast neoplasms * plans to undergo an elective alnd of berg's levels i and ii due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the slnb in the intraoperative or in the differed analysis. exclusion criteria: * allergy to any of the antibiotic drugs used * chronic renal failure due to possible toxicity of gentamicin * patients undergoing a modified radical mastectomy.
comparison of serum contraceptive hormone levels between normal weight and obese users of the nuvaring®

Conditions: Pharmacokinetics

Summary: there are over 60 million women of reproductive age in the u.s. and a majority of these women qualify as overweight or obese. evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. studies with the combined hormonal contraceptive patch (evra®) and the subdermal contraceptive implant (norplant®) demonstrate higher failure rates in heavier versus lighter women. weight related differences in the effectiveness of nuvaring® need further study. a single secondary analysis of pooled data from phase iii clinical trials of nuvaring® noted no difference in pregnancy rates among women in the highest weight decile (\>166#) versus the rest of the study population using the ring. (westhoff, 2005) the finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. this investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the nuvaring® . this study was a prospective clinical trial. normal weight women are defined as women with a bmi 19-24.9 and obese women are those with a bmi 30-39.9. we recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). we compared mean serum concentrations of ethinyl estradiol (e2) and etonogestrel (eng) along with additional markers for ovarian suppression. these markers included sonographic evidence of follicular development and ovulation as well as circulating e2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of nuvaring® use. assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. subjects also logged patterns of ring use and bleeding patterns during the study period.


Eligibility criteria:
inclusion criteria: * 18-35 yo * meet bmi requirements * weight stable * english speaking * desire contraception * history of regular menses with normal uterus and ovaries * medically eligible for combined hormonal contraception * tolerates phlebotomy/tvs exclusion criteria: * exclusion: * heavy smokers * users of medications that alter hormone levels

Keywords: contraceptive ring obesity pharmacokinetics pharmacodynamics pharmacokinetics of the contraceptive ring in obese women.
laser-assisted gingival depigmentation

Conditions: Hyperpigmentation; Melanin; Laser-Induced Hyperpigmentation

Summary: this randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; diode 940 nm and er,cr:ysgg 2780 nm.

this study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and erbium, chromium-doped yttrium, scandium, gallium and garnet (er,cr:ysgg) 2780 nm. two pigmentation index were used to compare between the treatment outcomes of using diode laser or er,cr:ysgg. the depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation. sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between april 2015 and september 2018. participants were randomly divided into 2 groups (30 patients each). randomization was carried out using randomization table; by a computer-generated randomization list (spss v23.0) with allocation ratio 1:1. all of the patients were selected according to the study inclusion and exclusion criteria. data collection was done by a dental specialist who was blinded about the provided treatment. data collections included the clinical examination at baseline and follow up appointments. to achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (dopi) and melanin pigmentation index. the periodontal surgery was performed by a periodontist specialised in laser dentistry. the periodontist did not interfere with the treatment option. descriptive statistics and statistical analysis was done by an external expert using spss statistics software(spss v23.0) . nonparametric tests, kruskal-wallis test was used to compare between the two groups according the time intervals. the patients who did not show in all the study follow up's appointments were dropped from the data analysis. patients were asked to evaluate the procedure by using a self-administered questionnaire. the patients were recalled after 1 week, 1 month, 12 months and 24 months.

Eligibility criteria:
inclusion criteria: • all patient exhibiting physiologic pigmentation of score2 or more according to oral pigmentation index (dopi) exclusion criteria: * pathologic hyperpigmentation * participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases) * pregnancy and lactation * history of smoking * previous mucogingival surgery at the region to be treated * no contraindication for the laser treatment.

Keywords: depigmentation gingival hyperpigmentation diode laser er,cr:ysgg laser repigmentation
a study with combination treatment (tamsulosin hydrochloride and solifenacin succinate) in male patients with luts/bph

Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Summary: the study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with luts associated with bph.

placebo solifenacin succinate tamsulosin hydrochloride tamsulosin hydrochloride + solifenacin succinate the primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy. other comparisons will be: placebo and combination treatment. solifenacin monotherapy and combination treatment

Eligibility criteria:
inclusion criteria: * male patients with luts associated with bph diagnosed \> 3 months * ipss score \> 13 * voiding and storage symptoms * maximum flow rate of \> 4 ml/s and \< 15 ml/s exclusion criteria: * post void residual volume \> 200 ml * symptomatic urinary tract infection

Keywords: lower urinary tract symptoms treatment solifenacin succinate tamsulosin hydrochloride prostatic hyperplasia
chronic adaptations to spinal flexion exposure

Conditions: Occupational Exposure

Summary: an experimental study, which will aim to compare changes of trunk mechanical properties and neuromuscular control following spinal flexion exposure in crane operators and control subjects.

our experimental study will include 40 participants, more specifically 15 crane operators and 15 control subjects. all participants will complete a 60-min protocol of intermittent trunk flexion. measurements of trunk mechanical properties and neuromuscular control will be performed prior to and following the 60-min protocol.

Eligibility criteria:
inclusion criteria: * crane operators: employed as crane operators for more than 3 years * occupational workers with a predominantly non static job (e.g. combination of sitting and standing) exclusion criteria: * history of chronic low back pain * episode of acute low back pain * hip injury in the past six months * previous spine, pelvis or hip surgery * hypermobility, diagnosed with the beighton score * high intensity resistance training (\> 75 % of 1 repetition maximum) more than two times a week * control group: sporting or recreational activities, that include repetitive spinal flexion or maintenance of a flexed posture (for example cycling or rowing).
performance of two sclera fixated intraocular lens concepts

Conditions: Cataract Complicated; Cataract Complications Operations

Summary: to evaluate and compare the post-operative outcome of two different sceral fixated iol concepts, the yamane method (za9003, j\&j, usa) and the carlevale iol (fil-ssf, soleko, italy).

various approaches to fix the haptics in the sclera can be found in literature. a distinction can be made between suture-fixed and sutureless techniques. the former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years. the popular yamane technique or "flanged iol fixation" uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. however, the haptics must be bent for this purpose thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the iol, it is also prone to dislocation and tilt. a more recent approach is the carlevale fil-ssf iol (soleko, italy), which was developed specifically for use in aphakia with a lack of capsular stability. using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. these two self-blocking anchors also provide a great deal of stability. the extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. thus, the carlevale technique represents a new, potentially superior option for intrascleral fixation. however, all these types of implantation are not free from aberrations, tilt, or even dislocation. many factors influence the outcome of iol implantation, the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. as part of quality management, an evaluation of monthly and six-monthly data will be performed. the aim of this study is the evaluation of the postoperative tilt of the carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment. the collected data is then evaluated and analyzed as well as compared to the yamane data.

Eligibility criteria:
inclusion criteria: * minimum age of 21 years * planned surgery or already taken place surgery using a scleral fixated lens exclusion criteria: * best corrected visual acuity \<0.05 snellen * pregnancy * missing informed consent form
efficacy and safety of empagliflozin versus sitagliptin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. the study will assess non-inferiority of empagliflozin to sitagliptin with regards to hba1c.


Eligibility criteria:
inclusion criteria: inclusion criteria: * diagnosis of type 2 diabetes mellitus. * male and female patients on diet and exercise regimen who are: * treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation. or * pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. minimum dose for metformin: \>=1500 mg/day or maximum tolerated dose or maximum dose according to local label. * hba1c of \>= 7.5 % and \<= 10.5 % at visit 1 and 3. * age \>= 18 yrs. exclusion criteria: * uncontrolled hyperglycaemia with a glucose level \>270 mg/dl (\>15 mmol/l) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in. * any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients). * any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin). * acute coronary syndrome (non-stemi, stemi and unstable angina pectoris), stroke or tia within 3 months prior to informed consent. * indication of liver disease. * moderate to severe renal impairment. * bariatric surgery within the past two years. * treatment with anti-obesity drugs 3 months prior to informed consent. * current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.
adhesive tape trauma evaluation of two gentle tapes

Conditions: Adhesive Tape Trauma

Summary: the objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. a three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

the objective of this study is to determine the relative gentleness of a new investigational tape compared to 3m micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. a three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

Eligibility criteria:
inclusion criteria: 1. who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema 2. who are between the ages of 6 months - 4 years of age 3. who has a fitzpatrick skin type of i, ii or iii 4. subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date 5. whose parent is willing to sign the informed consent form. exclusion criteria: 1. who are known to be developmentally delayed 2. who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites 3. who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study. 4. who have had a strep infection within the past 2 weeks 5. who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions 6. who have allergies to isocyanates, or acrylate adhesive products 7. who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (tylenol is an acceptable pain reliever).

Keywords: skin condition after wear